33 drug samples fail to clear CDSCO test, 2 declared misbranded

Published On 2022-01-23 07:45 GMT   |   Update On 2023-10-21 05:55 GMT

New Delhi: In its latest drug safety alert, the apex drug regulatory body, the Central Drugs Standard Control Organization (CDSCO), flagged 33 medicine batches for failing to qualify for a random drug sample test for the month of December, while two drug samples have been declared misbranded.

These drug samples which are declared not of standard quality include Mascot Health Serie's Colchicine Tablets I.P. 0.5 mg, Innova Captab's VERMIKIND- 12 (Ivermectin Dispersible Tablets), Stadmed's Disilox MPS (Aluminium, Magnesium and Simethicone Oral Suspension I.P.), Skymap Pharmaceuticals' Trimetazidine Modified Release Tablets 35 mg, SGS Pharmaceutical's Metronidazole Tablets IP (METRONIDAZOLE400), Skymap Pharmaceuticals' Omeprazole GastroResistant Capsules IP 20 mg etc.

In addition, other popular drug samples that are declared not of standard quality include samples from Sun Pharma's Volini pain relief spray containing Diclofenac Diethylamine; Linseed Oil, Methyl Salicylate & Menthol Topical Spray, and GlaxoSmithKline Pharmaceuticals' Betnovate-N Cream containing Betamethasone, Valerate, and Neomycin.

Apart from this, the popular covid drug, Remdesivir For Injection 100 mg/vial (COVIFOR), manufactured by Hetero Labs, is also on the list.

Further, the list contains two misbranded drugs: Primaquine Tablets IP and Diazepam Injection I.P. (Diazelab).

This came after analysis and tests conducted by the CDSCO Drugs Control Department on 1385 samples. Out of these, 1350 samples were found to be of standard quality, while 33 of them were declared as not of standard quality (NSQ), and 2 drugs were declared misbranded.

A few of the reasons why the drug samples tested failed were the failure of the assay, the failure of the dissolution test, the failure of disintegration, and the failure of the identification test.

The samples collected were tested in five laboratories, namely CDL Kolkata, CDTL Mumbai, RDTL Chandigarh, RDTL Guwahati, and CDTL Hyderabad.

List of Drugs, Medical Devices and Cosmetics declared as Not of Standard Quality/Spurious/Adulterated/Misbranded, for the Month of December – 2021:

Total number of samples tested

1385

Total number of samples declared as of Standard Quality

1350

Total number of samples declared as Not of Standard Quality

33

Total number of samples declared as Spurious

0

Total number of samples declared as Misbranded

02


S.No.

Name of Drugs/medical device/cosmetics

Batch No./Date of Manufacture/Date of Expiry/Manufactured

By

Reason for failure

Drawn By

From

1.

Colchicine 0.5 Tablets (Colchicine Tablets I.P.

0.5 mg)

B. No.: MT201577

Mfg dt: 07/2020 Exp dt: 06/2022

Mfd by: M/s. Mascot Health Series Pvt. Ltd., Plot No. 79, 80,

Sector- 6A, IIE, Sidcul,

Haridwar -249403 Uttarakhand.

Related Substances

CDSCO,

Visakhapatnam

CDL

Kolkata

2.

Tuscure Syrup (Chlorpheniramine, Phenylephrine & Dextromethorphan Syrup), 100 ml

B. No.: ALA2101 Mfg dt: 01/2021 Exp dt: 12/2022

Mfd by: M/s. MMC Healthcare Ltd., No. 34-B, SIDCO Industrial Estate, Thirumazhisai, Chennai -600124.

Assay of Phenylepheri ne Hydrochloride

CDSCO

South Zone Chennai

CDL

Kolkata

3.

COVIFOR (Remdesivir For Injection

100 mg/vial)

B. No.: REM121006A Mfg dt: 03/2021

Exp dt: 11/2021 Mfd by: M/s. Hetero Labs Limited, Hyderabad, India,

Manufactured At:

Aspiro Pharma Limited, Survey No. 321, Biotech Park, Phase-III, Karkapatia Village, Markook Mandal, Siddipet Dist., Telagana State – 502 281, India.

Particulate Matter, Clarity of Solution, Identification and Assay

Sub-Zone Baddi

CDL

Kolkata


4.

VERMIKIND - 12

(Ivermectin Dispersible Tablets)

B. No.: C3FHT015 Mfg dt: 10/2020 Exp dt: 09/2023 Mfd by: M/s. Innova

Captab Ltd., 1281/1,

Hiltop Industrial Estate, Near EPIP, Phase-1, Jharmajri, Baddi, Distt. Solan, Himachal Pradesh -173205.

Uniformity of Dispersion

CDSCO

East Zone Kolkata

CDL

Kolkata

5.

ZINCOPAC BOOST

Tablets (Zinc Acetate Tablets

50 mg)

B. No.: APT/04418

Mfg dt: 05/2021 Exp dt: 04/2023 Mfd by: M/s Amkon

Pharmaceuticals, Plot No. 242, Phase-9, Industrial Area, Mohali,

Punjab -160 062.

Assay of Elemental Zinc

CDSCO

East Zone Kolkata

CDL

Kolkata

6.

RESENT

(Ondansetron HCl Tablets I.P. 4 mg)

B. No.: 3233

Mfg dt: 06/2021 Exp dt: 05/2023

Mfd by: M/s. Infinitive Pharmaceutical Industries, Plot No.63,

G.I.D.C. Industrial Estate, Deesa, Gujarat

- 385535.

Dissolution

CDSCO

West Zone Mumbai

CDTL

Mumbai

7.

Trypsin Chymotrypsin Tablets

B. No.: MT193963

Mfg dt: 02/2020 Exp dt: 01/2022

Mfd by: M/s. Mascot Health Series Pvt Ltd., Plot No. 79, 80, Sector 6 A, IIE, Sidcul, Haridwar - 249 403

Uttarakhand.

Disintegration test

CDSCO

West Zone Mumbai

CDTL

Mumbai

8.

Disilox MPS (Aluminium, Magnesium and Simethicone Oral Suspension I.P.)

B. No.: C22C105

Mfg dt: 06/2021 Exp dt: 05/2024

Mfd by: M/s. Stadmed Private Limited, 15, Jawpore Road, Kolkata 700074.

Microbial contaminatio n in total aerobic viable count and presence of pathogens

(E.coli.)

CDSCO

Sub-Zone Goa

CDTL

Mumbai

9.

Disilox MPS (Aluminium, Magnesium and

B. No.: C22E106

Mfg dt: 08/2021 Exp dt: 07/2024

Microbial contaminatio n in total

CDSCO

Sub-Zone Goa

CDTL

Mumbai


Simethicone Oral Suspension I.P.)

Mfd by: M/s. Stadmed Private Limited, 15, Jawpore Road, Kolkata 700074.

aerobic viable count

10.

Disilox MPS (Aluminium, Magnesium and Simethicone Oral Suspension I.P.)

B. No.: C22E107

Mfg dt: 08/2021 Exp dt: 07/2024

Mfd by: M/s. Stadmed Private Limited, 15, Jawpore Road, Kolkata 700074.

Microbial contaminatio n in total aerobic viable count and presence of pathogens

(E. coli.)

CDSCO

Sub-Zone Goa

CDTL

Mumbai

11.

Trimetazidine Modified Release Tablets 35 mg

B. No.: GM21063

Mfg dt: 06/2021 Exp dt: 05/2023

Mfd by: M/s. Skymap Pharmaceuticals Pvt Ltd., B-3, Dev Bhoomi Industrial Estate, Puhana Iqbalpur Road, Roorkee- 247667 Uttarakhand.

Average weight

CDSCO

West Zone Mumbai

CDTL

Mumbai

12.

Trimetazidine Modified Release Tablets 35 mg

B. No.: GM20173

Mfg dt: 11/2020 Exp dt: 10/2022

Mfd by: M/s. Skymap Pharmaceuticals Pvt Ltd., B-3, Dev Bhoomi Industrial Estate, Puhana Iqbalpur Road, Roorkee- 247667

Uttarakhand.

Average weight

CDSCO

West Zone Mumbai

CDTL

Mumbai

13.

CLODOSPIN B Lotion (Clotrimazole & Beclomethasone Dipropionate Lotion)

B. No.: CS2101 Mfg dt: 04/2021 Exp dt: 03/2023 Mfd by: M/s. Yash

Pharma Laboratories

Pvt. Ltd., Khasra No. 19-M, Village : Raipur, Pargana : Bhagwanpur, Tehsil : Roorkee, Dist : Haridwar- 247661 Uttarakhand.

Microbial contaminatio n &

Assay of Beclomethas one Dipropionate

CDSCO

Sub-Zone Goa

CDTL

Mumbai

14.

Themidon (Trimetazidine Dihydrochloride Tablets IP)

B. No.: TDN003 Mfg dt: 07/2020 Exp dt: 06/2023

Mfd by: M/s. Themis

Assay

CDSCO

West Zone Mumbai

CDTL

Mumbai


Medicare Limited., Sector 6A, Plot No.16, 17 & 18, IIE, SIDCUL,

Haridwar – 249 403,

Uttarakhand.

15.

DICLOFENAC SODIUM TABLETS

I.P. 50mg

B. No.: DF11 Mfg dt: 07/2021 Exp dt: 06/2023

Mfd by: M/s. Suzikem Drugs Pvt. Ltd., Plot No. 205/2A, IDA

Cherlapalli, Phase II, Medchal Malkajgiri District , Hyderabad- 500051.

Disintegration (Acid Stage)

CDSCO

Hyderabad Zone

CDTL

Hyderabad

16.

MECOBALAMIN, FOLIC ACID, ALPHA LIPOIC ACID, PYRIDOXINE HCI & THIAMINE HCI TABLETS (COBAL® FORTE)

B. No.: BM3002 Mfg dt: 09/2020 Exp dt: 08/2022

Mfd by: M/s. Bio Neutraceuticals, 8- 290/1, Groud Floor, Goutham Nagar, Ferozguda, Secunderabad -

500011, Telangana.

Disintegration and Assay of Mecobalamin

, Alpha Lipoic Acid and Thiamine Hydrochloride

CDSCO

Hyderabad Zone

CDTL

Hyderabad

17.

(PANTOPRAZOLE FOR INJECTION BP 40 MG)

B. No.: AA010102

Mfg dt: 05/2020 Exp dt: 04/2022 Mfd by: M/s. ANG

Lifesciences India Ltd.

Village: Kishanpura, Nalagarh Road, Tehsil: Baddi, Distt: Solan,

Himachal Pradesh - 174101.

Particulate matter

Drug Control Department Delhi

RDTL

Chandigarh

18.

Cefpodoxime Proxetil Dispersible Tablets 200 mg (POME 200 TABLETS)

B. No.: WJT-175J Mfg dt: 08/2021 Exp dt: 07/2023

Mfd by: M/s. WELCURE

REMEDIES Nahan Road, Vill.Moginand, Distt. Sirmour-173030

Himachal Pradesh.

Disintegration Test

CDSCO

Sub - Zone Baddi

RDTL

Chandigarh

19.

Betamethasone Valerate and

B. No.: FC989

Identification

Drug Control Department

RDTL

Chandigarh


Neomycin Skin Cream (BETNOVATE-N CREAM)

Mfg dt: 05/2021 Exp dt: 10/2022 Mfd by: M/s.

GlaxoSmithKline

Pharmaceuticals Limited At: Plot No. C- 1, Madkaim Industrial Estate, Madkaim,

Post-Mardol, Ponda, Goa 403404.

Delhi

20.

Diclofenac Diethylamine; Linseed Oil; Methyl Salicylate & Menthol Topical Spray (VOLINI PAIN RELIEF SPRAY)

B. No.: XDY0036 Mfg dt: 08/2021 Exp dt: 07/2023 Mfd by: M/s sun

pharmaceutical ind.ltd. At: V.P.O.Bathu, Teh. Haroli. Himachal Pradesh, Dist. Una-

174301.

Identification (Negative for Diclofenac Diethylamine and Linseed oil) and Assay of Methyl Salicylate, Menthol.

Drug Control Department Delhi

RDTL

Chandigarh

21.

(ZINC SULPHATE DISPERSIBLE TABLETS IP)

B. No.: ZST21024 Mfg dt: 07/2021 Exp dt: 06/2023 Mfd by: M/s. LA-

CHEMICO PRIVATE

LIMITED Taki Road Kadambagachi, Barasat, North 24- Parganas, West Bengal, Kolkata- 700125, West Bengal.

Disintegration Test

CDSCO

Sub Zone Jammu

RDTL

Chandigarh

22.

Acebrophylline (SR), Fexofenadine Hydrochloride and Montelukast Sodium Tablets (LEVOICE-3D TABLETS)

B. No.: T21G522D Mfg dt: 07/2021 Exp dt: 06/2023 Mfd by: M/s. Bajaj

Formulations Khasra

No. 161, Village Lakeshwary, Bhagwanpur, Roorkee, distt. Haridwar Uttarakhand.

Assay of Montelukast Sodium calculated as Montelukast

Drug Control Department Srinagar

RDTL

Chandigarh

23.

COLGATE DENTAL CREAM ANTICAVITY TOOTHPASTE

B. No.: B19 Mfg dt: 06/2021 Exp dt: 05/2023 Mfd by: M/s. COLGATE-

PALMOLIVE (INDIA)

Appearance, Dispensing, Particle feel on butter paper, Total Microbial

Count, Total

Drug Control Department Delhi

RDTL

Chandigarh


LIMITED Code IN12

Address Not Mentioned.

Yeast and Mould Count

24.

DROTAVERINE HYDROCHLORIDE IP

B. No.: DTV/170/2021

Mfg dt: 10/2021 Exp dt: 09/2026 Mfd by: M/s. Punjab Chemical & Crop Protection Limited Village: Koli Majra,

Samalher, P.O.-Lalru, Distt. SAS Nagar, (Mohali) Punjab,

INDIA.

Loss on Drying

CDSCO

Sub-Zone Guwahati

RDTL

Chandigarh

25.

Trypsin, Bromelain & Rutoside Trihydrate

Tablets

B. No.: GT200466

Mfg dt: 03/2020 Exp dt: 02/2022 Mfd by: M/s. Theon

Pharmaceuticals Ltd.

Vill. Saini Majra,Teh. Nalagarh, Distt. Solan Himachal Pradesh -

174101.

Description

CDSCO

Sub-Zone

RDTL

Guwahati

26.

Pantoprazole Gastro Resistant Tablets IP

B. No.: TD20-16

Mfg dt: 04/2020 Exp dt: 03/2022 Mfd by: M/s. Om Biomedic Pvt Ltd,

Plot No. 68, 69, 82 &

83, Sector-6A, IIE,

SIDCUL, Haridwar– 249403 Uttarakhand.

Dissolution (Buffer stage)

Drug Control Department Assam

RDTL

Guwahati

27.

Metronidazole Tablets IP (METRONIDAZOLE- 400)

B. No.: TMRL-036 Mfg dt: 12/2020 Exp dt: 11/2023 Mfd by: M/s. SGS

PHARMACEUTICAL

(P) LTD. E-13/1, Sec- 17, Kavi Nagar, Indl. Area, Ghaziabad – 201002, Uttar

Pradesh.

Dissolution

Drug Control Department Jharkhand

RDTL

Guwahati

28.

Diazepam Injection I.P. (Diazelab)

B. No.: KDZI-001

Mfg dt: 02/2020 Exp dt: 01/2022

Misbranded

Drug Control Department Bihar

RDTL

Guwahati


Mfd by: M/s. Laborate Pharmaceutical

India Ltd, (Unit-II) #31, Rajban Road, Nariwala, Paonta Sahib, Himachal Pradesh.

29.

Ciprofloxacin Tablets

I.P. 500 mg. (Cipronir-500)

B. No.: CCF912011

Mfg dt: 12/2019 Exp dt: 11/2022

Mfd by: M/s. Celebrity Biopharma Ltd.

Village- Panga, Via – Jharmajri, Hill Top Estate, Barotiwala, Dist. – Solan, Himachal .Pradesh - 174103.

Dissolution

Drug Control Department Jharkhand

RDTL

Guwahati

30.

Telmisartan Tablets IP 40 mg

B. No.: TETY-01 Mfg dt: 04/2021 Exp dt: 03/2023

Mfd by: M/s. NESTOR PHARMACEUTICALS

LIMITED, 11, Western Extension Area, Faridabad-121001, Haryana INDIA.

Dissolution

Drug Control Department Jharkhand

RDTL

Guwahati

31.

Dexamethasone Sodium Phosphate Injection IP

B. No.: I-131

Mfg dt: 04/2021 Exp dt: 03/2023

Mfd by: M/s. Jackson Laboratories Pvt. Ltd. 22-24, Majitha Road, Bye pass, Amritsar-

143001,Punjab (India).

Assay

Drug Control Department Jharkhand

RDTL

Guwahati

32.

Omeprazole Gastro- Resistant Capsules IP 20 mg

B. No.: GM20126

Mfg dt: 11/2020 Exp dt: 10/2022

Mfd by: M/s. Skymap Pharmaceuticals Pvt. Ltd., B-3, Dev Bhoomi Industrial Estate, Puhana, Iqbalpur road, Roorkee – 247667

Uttarakhand.

Dissolution

CDSCO

Sub-Zone Guwahati

RDTL

Guwahati

33.

Omeprazole Capsule

I.P. 20 mg.

B. No.: SBC-20/021

Mfg dt: 03/2020

Dissolution

Drug Control Department

Jharkhand

RDTL

Guwahati


Exp dt: 02/2022 Mfd by: M/s.

Supercure Biotech

Private Limited, Plot No. 99/4/1,

Friends Colony, G.T. Road, Kundali, Haryana-131028 (India).

34.

Primaquine Tablets IP

B. No.: AHT-2769 Mfg dt: 10/2021 Exp dt: 09/2023 Mfd by: M/s. Not

readable/not visible/not appeared in a conspicuous manner

on the label.

Misbranded

CDSCO

Sub-Zone Guwahati

RDTL

Guwahati

35.

Ciprofloxacin Hydrochloride Tablets

I.P. 500 mg.

B. No.: 0702420

Mfg dt: 06/2020 Exp dt: 05/2023

Mfd by: M/s. Karnataka Antibiotics & Pharmaceuticals Limited, (A Govt. of India Enterprise) Plot no. 14, II Phase, Peenya, Bengaluru-

560058, Karnataka.

Dissolution

Drug Control Department Jharkhand

RDTL

Guwahati

Also Read:42 drug samples fail to qualify CDSCO test, 1 declared misbranded

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